WO2012082628A1

WO2012082628A1 - User interface related to a surgical provisional

Info

Publication number: WO2012082628A1
Application number: PCT/US2011/064435
Authority: WO
Inventors: Jody L. Claypool; Joel F. Zuhars; Stuart Sullivan; David B. Rich
Original assignee: Zimmer, Inc.
Priority date: 2010-12-17
Filing date: 2011-12-12
Publication date: 2012-06-21
Also published as: CA2824527A1; JP6043318B2; US8603101B2; EP3335674A3; JP2014508554A; CA2824527C; US20160324647A1; EP2651327A1; AU2011343440A1; CN103379880A; JP2014505517A; CN105055052A; ES2622842T3; CN105055052B; EP2651327B1; US20140052269A1; ES2772727T3; US20130253378A1; EP3335674B1; CA2821927A1

Abstract

Systems and methods for presenting force information related to a provisional is disclosed. A user interface may be provided for presenting objects on a display related to a knee joint, the user interface including a representation of an area of the knee joint for presentment on the display and a force center indicator for presentment on the display. The user interface providing an indication of when a position of the force center indicator corresponds to a desired position of the force center indicator.

Description

ZIM0875-20/ZI-00751

[0001] The entire disclosure of US Provisional Application Serial No, 61/424,222, filed December 17, 201 1, titled USER INTERFACE RELATED TO A SURGICAL

PROVISIONAL, docket ZIM0875 is hereby expressly incorporated by reference herein.

BACKGROUND AND SUMMARY

[0002] The present disclosure relates generally to orthopedic devices and in particular to orthopedic devices including sensors and a user interface of a computing device associated with the orthopedic device.

[0003] In a knee replacement procedure, a provisional device may be inserted in the joint to assist in determining the size of tibia implant to use. A height of the provisional device may be increased with shims.

[0004] In an exemplar}_' embodiment of the present disclosure, a user interface generated with a computing device by instructions stored on at least one computer-readable medium is provided. The user interface presenting on a display objects related to a knee joint At least one of the objects being based on data from a plurality of sensors which are located between the femur and the tibia. The user interface comprising a representation of an area of the knee joint for presentment on the display; and a force center indicator for presentment on the display. The user interface providing an indication of when a position of the force center indicator corresponds to a desired position of the force center indicator. The position of the

1

BDDB01 9027443vl ZIM0875-20/ZI-00751 force center indicator being determined by an electronic controller of the computing device based on data from the plurality of sensors.

[0005] In another exemplary embodiment of the present disclosure, a user interface generated with a computing device by instructions stored on at least one comp ter-readable medium is provided. The user interface presenting objects on a display related to a knee joint. At least one of the objects being based on data from a plurality of sensors which are located between the femur and the tibia and supported by a device having a posterior ridge. The user interface comprising a representation of an area of the knee joint for presentment on the display; and at least one indicator for presentment on the display, the at least one indicator indicating a force level on the posterior ridge of the device. The force level on the posterior ridge being determined by an electronic controller of the computing device based on data from the plurality of sensors.

[0006] In yet another exemplary embodiment of the present disclosure, a user

interface generated with a computing device by instructions stored on at least one computer- readable medium is provided. The user interface presenting objects on a display related to a knee joint. At least one of the objects being based on data from a plurality of sensors which are located between the femur and the tibia. The user interface comprising a representation of an area of the knee joint for presentment on the display; an overall force center indicator for presentment on the display relative to the representation; a medial force center indicator for presentment on the display relative to the representation; and a lateral force center indicator for presentment on the display relative to the representation, a position of the overall force

BDDB01 9027443vl ZIM0875-20/ZI-00751 center indicator, a position of the medial force center indicator, and a position of the lateral force center indicator being determined by an electronic controller of the computing device based on data from the plurality of sensors,

[0007] In still another exemplar}_' embodiment of the present disclosure, a user interface generated with a computing device by instructions stored on at least one computer- readable medium is provided, The user interface presenting objects on a display related to a knee joint. At least one of the ob jects being based on data from a plurality of sensors which are located between the femur and the tibia. The user interface comprising a representation of an area of the knee joint for presentment on the display; and at least one indicator for

presentment on the display, the at least one indicator indicating a force level on a post of the device which is received in a recess in one of the femur and the tibia, the force level on the post being determined by an electronic controller of the computing device based on data from the plurality of sensors,

[0008] In a further exemplary embodiment of the present disclosure, a user interface generated with a computing device by instructions stored on at least one computer-readable medium is provided. The user interface presenting objects on a display related to a knee joint. At least one of the objects being based on data from a plurality of sensors which are located between the femur and the tibia. The user interface comprising a representation of an area of the knee joint for presentment on the display; a force center indicator for presentment on the display; and a spread force indicator for presentment on the display. The spread force indicator providing an indication of a spread of the forces across the area of the knee joint.

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BDDB01 9027443vl ZIM0875-20/ZI-00751

The position of the force center indicator and the spread force indicator being determined by an electronic controller of the computing device based on da ta from the plurality of sensors.

[0009] In a yet further exemplary embodiment of the present disclosure, a user interface generated with a computing device by instructions stored on at least one computer- readable medium is provided. The user interface presenting objects on a display related to a knee joint. At least one of the objects being based on data from a plurality of sensors which are located between the femur and the tibia. The user interface comprising a representation of an area of the knee joint for presentment on the display; and a force center indicator for presentment on the display. The user interface providing an indication of a first position of the force center indicator when the knee joint is in a first position and of a second position of the force center indicator when the knee joint is in a second position. The first position of the force center indicator and the second position of the force center indicator being determined by an el ectronic controller of the computing device based on data from the plurality of sensors.

[0010] In a still further exemplary embodiment of the present disclosure, a user interface generated with a computing device by instructions stored on at least one computer- readable medium is provided. The user interface for presenting objects on a display related to a knee joint. At least one of the objects being based on data from a plurality of sensors which are located between the femur and the tibia, The user interface comprising a representation of an area of the knee joint for presentment on the display; and a force center indicator for presentment on the display. The user interface providing an indication of a first position of

4

BDDB01 9027443vl ZIM0875-20/ZI-00751 the force center indicator when the knee joint is in a first position and of a second position of the force center indicator when the knee joint is in the first position. The first position of the force center indicator corresponding to a first environment for the knee joint and the second position of the force center indicator corresponding to a second environment of the knee joint. The first position of the force center indicator and the second position of the force center indicator being determined by an electronic controller of the computing device based on data from the plurality of sensors.

[0011] In a yet still further exemplary embodiment of the present disclosure, a system for evaluating a knee joint is provided. The system comprising a provisional selected from a plurality of provisionals, the provisional including a plurality of sensors which are located between the femur and the tibia when the provisional is positioned in the knee joint; and a computing system including a display. The computing system executes a processing

sequence to identify the provisional and presents a user interface on the display to provide an indication of the force experienced by die plurality of sensors.

[0012] In still yet another exemplary embodiment of the present disclosure, a user interface generated with a computing device by instructions stored on at least one computer- readable medium is provided. The user interface presenting objects on a display related to a simulation of a knee joint. The user interface comprising at least one input to specify force readings across an area of the knee joint; and a force center indicator for presentment on the display. The user interface providing an indication of a position of the force center indicator relative to a desired position of the force center indicator, the position of the force center

^■ 5 -

BDDB01 9027443vl ZIM0875-20/ZI-00751 indicator being determined by an electronic controller of the computing device based on the specified force readings across the area of the knee joint.

[0013] In still a further exemplary embodiment of the present disclosure, a user interface generated with a computing device by instructions stored on at least one computer- readable medium is provided. The user interface presenting objects on a display related to a simulation of a knee joint. The user interface comprising at least one input to specify

simulation force readings across an area of the knee joint, each force reading corresponding to a respective sensor of a pro visional; and at least one visual indicator for presentment on the display, the at least one visual indicator providing a visual cue of the force experienced by the provisional based on the simulation force readings.

[0014] In yet still another exemplar}' embodiment of the presen t disclosure, a method of analyzing forces on a provisional placed in a knee joint is provided. The method

comprising the steps of receiving from the provisional information related to the provisional, the pro visional including a plurality of sensors, the information related to the provisional including at least one of identifying information for the provisional, location information of the plurality of sensors of the provisional, and a visual representation of the provisional;

electronically receiving from the provisional information related to a force experienced by the plurality of sensors of the provisional; and determining a t least one measure of the force experienced by the provisional from the information related to the force experienced by the plurality of sensors.

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BDDB01 9027443vl ZIM0875-20/ZI-00751

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The foregoing aspects and many of the a ttendant advantages of this invention will become more readily appreciated as the same become better understood by reference to the following detailed description when taken in conjunction with the accompanying

drawings.

[0016] FIG. 1 is a representative view of an exemplary knee joint being evaluated with a sensing provisional;

[0017] FIG. 2 is a representative vie of a portion of the sensing provisional of FIG. i;

[0018] FIG. 3 is a representative view of an exemplary computing system including force analysis software related to the sensing provisional of FIG. 1 and a user interface;

[001 ] FIG. 4 is a representative view of a network accessible by the exemplary computing system of FIG. 3;

[0020] FIG. 5 is a representative view of an exemplary display screen of the user interface of the exemplar}' computing system of FIG . 3 including a representation of a force center indicator of the forces experienced by the sensing provisional of FIG . 1 and a

representation of a desired location for the force center;

[0021] FIG. 6 is a representa tive view of another exemplary display screen of the user interface of FIG. 3 including representations of the force magnitude experienced by the sensors of the sensing provisional of FIG. 1 for FIG. 5;

BDDB01 9027443vl ZIM0875-20/ZI-00751

[0022] FIG. 7 is a representative view of the exemplary display screen of FIG. 5 of the user interface of the exemplary computing system of FIG. 3 wherein the force center indicator is medialized;

[0023] FIG. 8 is a representative view of the exemplary display screen of FIG. 6 corresponding to the force magnitude experienced by the sensors of the sensing provisional of FIG. 1 for FIG. 7;

[0024] FIG, 9 is a representative view of the exemplar}' display screen of FIG. 5 of the user interface of the exemplary computing system of FI G. 3 wherein the force center indicator is lateraiized;

[0025] FIG. 10 is a representative view of the exemplary display screen of FIG. 6 corresponding to the force magnitude experienced by the sensors of the sensing provisional of FIG. 1 for FIG. 9;

[ 0026] FIG. 1 1 is a representative view of the exemplary display screen of FIG. 5 of the user interface of the exemplary computing system of FIG. 3 wherein the force center indicator is positioned at a desired location for the force center;

[0027] FIG. 12 is a representative view of the exemplar display screen of FIG . 6 corresponding to the force magnitude experienced by the sensors of the sensing provisional of FIG. 1 for FIG. I I;

[0028] FIG. 13 is a representative view of the exemplar}' display screen of FIG, 5 of the user interface of the exemplary computing system of FIG. 3 related to another exemplary

BDDB01 9027443vl ZIM0875-20/ZI-00751 sensing provisional which includes sensors along the posterior ridge of the provisional and sensors related to a pos t region of the pro visional;

[0029] FIG, 13A is a representative view of the exemplary display screen of FIG. 13 including a representation of a multi-level representation of a desired location for the force center and force centers for each sensor compartment of the sensing provisional;

[0030] FIG. 14 is a representative view of the exemplary display screen of FIG. 6 corresponding to the force magnitude experienced by the sensors of the sensing provisional of FIG. 13;

[0031] FIG, 15 is a representative view of the exemplary display screen of FIG. 13 including a representa tion of a force indicator related to the post region of the provisional;

[0032] FIG, 16 is a representative view of the exemplar}' display screen of FIG, 6 corresponding to the force magnitude experienced by the sensors of the sensing prov isional of FIG. 15;

[0033] FIG. 17 is a representative view of the exemplar}' display screen of FIG. 13 including a representation of an exemplary spread force indicator;

[0034] FIG. 18 is a representative view of the exemplar display screen of FIG . 13 including a representation of another exemplar}' spread force indicator and a force indicator related to the post region of the pro visional;

[0035] FIG. 19 is a representative view of the exemplar}' display screen of FIG, 13 wherein the current locations of the force indicators are marked as corresponding to a full flexion position of the knee joint;

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BDDB01 9027443vl ZIM0875-20/ZI-00751

[0036] FIG. 20 is a representative view of the exemplary display screen of FIG, 13 wherein the current locations of the force indicators are marked as corresponding to a full extension position of the knee joint and including historical markers associated with the

current locations of the force indicators are marked as corresponding to the full flexion position of the knee joint in FIG. 19;

[0037] FIG. 21 is a representative view of the exemplary display screen of FIG. 13 wherein the current locations of the force indicators are marked as corresponding to a full extension position of the knee joint and including historical markers associated with the current locations of the force indicators are marked as corresponding to the full fl exion position of the knee joint in FIG. 19 and path indicators which provide the relative positions of the force indicators as the knee was at positions between full flexion and full extension;

[0038] FIG. 22 is a representati ve vie w of the exemplary display screen of F IG. 13 wherein the current locations of the force indicators are marked and including historical markers associated with multiple trials of the knee joint at full flexion and full extension;

[0039] FIG. 23 is a representative view of the exemplary display screen of FIG. 13 wherein the current l ocations of the force indicators are marked and including historical markers associated with multiple trials of the knee joint at full flexion and full extension and path indicators which provide the relative positions of the force indicators as the knee was at positions between full flexion and full extension for eac of the multiple trails; and

[0040] FIG. 24 is an exemplary display screen of a simulation tool.

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BDDB01 9027443vl ZIM0875-20/ZI-00751

[0041] Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent embodiments of various features and components according to the present disclosure, the drawings are not necessarily to scale and certain features may be exaggerated in order to better illustrate and explain the present disclosure. The exempl ification set out herein illustrates embodiments of the invention, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

DETAILED DESCRI PTION OF THE DRAWINGS

[0042] For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings, which are described below. The embodiments disclosed below are not intended to be exhaustive or limit the invention to the precise form disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may utilize their teachings. It will be understood that no limitation of the scope of the invention is thereby intended. The invention includes any alterations and further modifications in the illustrated devices and described methods and further applications of the principles of the invention which would normally occur to one skilled in the art to which the invention relates.

[0043] Referring to FIG. 1, a knee joint 10 is represented. The knee joint 10 includes a tibia bone 12 which has been resected to provide a resection surface 14, The knee joint 10 further includes a femur bone 16. A provisional 20 is shown being inserted between femur 16 and resection surface 14 of tibia 12 to simulate the fit of an implant in the knee joint 10.

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BDDB01 9027443vl ZIM0875-20/ZI-00751

[0044] Provisional 20 includes an upper portion 22 having a contoured top surface 24 which corresponds to the tibial articular surface of the implant to be used. Provisional 20 further includes a base portion 26 whic rests upon resection surface 14 of tibia 12. The fit of provisional 20 in tibia 12 may be adjusted by inserting one or more shims 30 between upper portion 22 and base portion 26 to adjust spacing between upper portion 22 and base portion 26.

[0045J Referring to FIG. 2, upper portion 22 includes a plurality o feree sensors positioned below contoured top surface 24. In one embodiment, the force sensors are embedded in upper portion 22. In the illustrated embodiment, upper portion 22 includes a first group 40 of force sensors, illustratively sensors 42A-C, and a second group 44 of force sensors, illustratively sensors 42D-F. Exemplary force sensors include force sensing resistor or capacitive flex circuits, piezoelectric film, piezoelectric elements, piezoresistive and piezoelectric polymers, metal foil strain gages, semiconductor strain gages, piezoresistive and capacitive pressure sensors, interferometric optical sensors, path displacement optical sensors, optical fiber force sensors, and other suitable sensing technologies.

[0046] Each of feree sensors 42 is operatively coupled to a controller 50 of

provisional 20. Controller 50 receives or otherwise monitors an indication of the amount of force experienced by each of the force sensors 42. Controller 50 communicates the force data to remote computing system 100 through a communication device 52, An exemplary

communication device 52 is a radio wave transmitter or other suitable devices for wireiessly transmitting information to a remote computing system 100, In one embodiment, the

12

BDDB01 9027443vl ZIM0875-20/ZI-00751 communication device further includes a receiver for receiving information from the remote computing system 100. In one embodiment, die controller 50 and the communication device 52 is supported by upper portion 22 of provisional 20.

[0047] In one embodiment, provisional 20 includes a unique data encoding which is stored in a memory associated with controller 50 and is provided through communication device 52 to computing system 100 to identify the provisional 20 being used. In one

example, computing system 100 then queries a provisional database 120 to retrieve

information regarding the identified provisional. In one example, provisional 20 through communication device 52 provides to computing system 100 information regarding the provisional 20. Exemplary information includes brand information, product line information, medial/lateral information, size information, poly thickness information, lot number, serial number, rendered images for use in the computing system graphical user interface, sensor configuration, calibration data, and other suitable information. This information may be used for recordation in a patient file, used for inventory management and traceabiiity. Further, the information includes information for display with a display 132 of remote computing device 100 including specific provisional surface geometry, sensor layout, and degree of constraint. In one embodiment, the provisional data may be uploaded from provisional 20 to computing system 100 on activation and connection of the provisional 20 with the computing system 100.

[0048] In one embodiment, provisional 20 or its associated packaging includes visible identification information. Exemplar}' identification information may be provided in or

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BDDB01 9027443vl ZIM0875-20/ZI-00751 determinable from a barcode. A camera associated with the computing device 100 captures an image including the identification information. In the case of a barcode, a scanner may be used in place of a camera. In one embodiment, the camera is integrated with the computing system 100. The identification information is extracted from the captured picture by

computing system 100. Computing system 100 then broadcasts a unique identifier retrieved as part of or associa ted with the identification information as part of a wireless pairing protocol. Exemplary wireless pairing protocols include Bluetooth, Zigbee, and other

protocols. The provisional 20 receives the broadcasted message and compares the broadcast unique identifier with a stored identifier, if the two match, the provisional 20 broadcasts its information to the computing system 100.

[0049] In one embodiment, provisional 20 broadcasts its unique identifier. The computing system 100 captures an image of identification information pro vided on the provisional or its packaging. If the unique identifier determined from the captured image corresponds to the unique identifier broadcasts by provisional 20, computing system 100 communicates with provisional 20,

[0050] In a similar fashion, each of shims 30 includes a unique data encoding which is provided through communication device 52 to computing system 100 to identify the shims 30 being used with provisional 20. In one embodiment, when a shim 30 is used with a

provisional 20, the shim 30 is automatically detected by provisional 20 and information regarding the shim 30 is relayed to computing system 100 along with the sensor data of provisional 20. In one example, the identification is made via a set of hall effect sensors that

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BDDB01 9027443vl ZIM0875-20/ZI-00751 form a bit pattern for controller 50. Each shim produces a unique bit pattern through an interaction with the hall effect sensors that is specific to the shim type or shim type

combination. Other suitable methods of identification may be used.

[0051 ] In one example, computing system 100 queries a shim database 118 to retrieve information regarding the identified shim 30. in one example, provisional 20 through communication device 52 provides to computing system 100 information regarding the identified shim 30. Exemplary information includes brand information, product line

information, thickness information, lot number, and other suitable information. This

information may be used for recordation in a patient file to update thickness data and

compensate algorithm calibrations accordingly, if necessary. In one embodiment, information regarding the identified shim is used in determining a joint angle, For example, if a joint angle is detected by computing system 100, the reported joint angle may be adjusted by the effective wedge angle of the shim combination, either in the anterior/posterior direction or the medial/lateral direction, as appropriate. The joint angle may be detected through the use of an integrated accelerometer, gyroscope, or combination of angular sensing devices, either internal or external to the provisional itself, or in combination with a corresponding angular sensing device attached to the femur.

[0052] In one embodiment, the informa tion regarding the identified pro visional 20 and the identified shims 30 is uploaded from provisional 20. Because all device specific data is uploaded from provisional 20, the application software of computing system 100 does not need to be upgraded to interface with a newly developed provisional 20 or shims 30.

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BDDB01 9027443vl ZIM0875-20/ZI-00751

[0053] Referring to FIG. 3, a computing system 100 is shown. Computing system

100 may be a stand alone computing device. Exemplar}_' stand alone computing devices include a general purpose computer, such as a desktop computer, a laptop computer, and a tablet computer, smartphone, handheld computing device, or other suitable computing devices. An exemplary computing device is the IP AD brand computing device available from Apple Computer located I Infinite Loop in Cupertino, CA 95014. Although computing system 100 is illustrated as a single computing system, it should be understood that multiple computing systems may be used together, such as over a network or other methods of transferring data.

[0054] In one embodiment, computing system 100 is attached to the surgical tabl e rails of a table supporting the patient, so that computing system 100 may be both physically small and within the immediate viewing space of the surgeon. In one embodiment, a display 132 of computing system 100 is a projected image. In one embodiment, a display 132 of computing system 100 is associated with the surgeon's glasses. In one embodiment, the computing system 100 or at least a display of computing system 100 is a handheld device intended to be held up by the circulating nurse for the surgeon to vie only during the relevant portion of the procedure.

[0055] In one embodiment, interaction with a graphical user interface of computing system 100 is a touch screen or mechanical switches which are engaged by the surgeon or nurse. In one embodiment, the surgeon or nurse interacts with the computing system through voice commands received by a microphone associated with the computing system. In one

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BDDB01 9027443vl ZIM0875-20/ZI-00751 example, the computing system is able to identify the voice of the surgeon or other authorized user. In one embodiment, the surgeon or nurse interacts with the computing system through gestures captured by a camera associated with the computing system. In any of the discussed embodiments, the computing system 100 or at least a display of the computing system 100 may be contained within a bag or other sterilization mechanism and the surgeon or other authorized user interacts with the computing system through the bag or other sterilization mechanism.

[0056] Computing system 100 has access to a memory 104 which is accessible by a controller 106 of computing system 100. Exemplary controllers include computer processors. Controller 106 executes software 108 stored on the memory 104. Memory 104 is a computer readable medium and may be a single storage device or may include multiple storage devices, located either locally with computing system 100 or accessible across a network. Computer- readable media may be any available media that may be accessed by controller 106 of computing system 100 and includes both volatile and non-volatile media . Further, computer readable-media may be one or both of removable and non-removable media. By way of example, computer-readable media may include, but is not limited to, RAM, ROM,

EEPRQM, flash memory or other memory technology, CD-ROM, Digital Versatile Disk

(DVD) or other optical disk storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which may be used to store the desired information and which may be accessed by computing system 100.

BDDB01 9027443vl ZIM0875-20/ZI-00751

[0057] emor}' 104 includes operating system software 110. An exemplary operating system software is a WINDOWS operating system available from Microsoft Corporation of Redmond, Washington, Memory 104 further includes communications software 1 12 which allows computing system 100 to communicate with one or more networks 150, such as a local area network, a wide area network, a public switched network, any type of wired network, any type of wireless network, and combinations thereof. An exemplar}' public switched network is the Internet. Exemplary communications software 1 12 includes browser software, and other types of software which permit computing system 100 to communicate with other devices across a network. In one embodiment, computing system 100 communicates with provisional 20 over an exemplary network 150. In one embodiment, computing system 100 also communicates with one or more additional computing devices over network 150, such as computing devices connected to a hospital network or surgery center network, in one embodiment, the software functions disclosed herein are implemented as hardware.

[0058] Memory 104 further includes force analysis software 114. Although described as software, it is understood that at least portions of the force analysis software 1 14 may, in some embodiments, be implemented as hardware.

[0059] As explained herein, force analysis software 1 14 receives an indication of the force measured by the sensors associated with provisional 20. Force analysis software 114 based on the measured force provides feedback for the operator through an output device 132 of a user interface 128, such as a display. Examples of the type feedback provided to the operator are disclosed herein and are illustrated in FIGS. 5-24.

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[0060] Also, as explained herein, force analysis software 114 may reference one or more of at least one force data database 116, at least one shim database 118, at least one provisional database 120, and at least one surgeon database 122. Force analysis software 1 14 stores force readings for provisional 20 in force database 1 16. in one embodiment, the force readings for each sensor are stored and time-stamped in force database 1 16.

[0061] In one embodiment, shim database 118 includes information regarding a plurality of shims 30 that may be used with a provisional 20 and provisional database 120 includes information regarding a plurality of provisionals 20. In one example, provisional database 120 for a given provisional 20 includes a sensor layout and an image to represent the provisional 20 on a display 132. As mentioned herein, in one embodiment, the information regarding the identified provisional 20 and any identified shims 30 is uploaded from

provisional 20 instead of being retrieved from pro visional database 120 and shim database 1 18, respectively.

[0062] In one embodiment, computing system 100 further includes a surgeon database

122 which stores information related to a plurality of surgeons. In one embodiment, a surgeon logs on or is otherwise identified by computing system 100 and any preference information or other surgeon specific information in surgeon database 122 is retrieved. In one embodiment, the surgeon chooses to have force data displayed and/or interpreted relative to a historical set of case data from that surgeon. This information may be stored in the surgeon database or stored in the patient database. In another embodiment, the surgeon chooses to have force data displayed and/or interpreted relative to a historical set of case data

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BDDB01 9027443vl ZIM0875-20/ZI-00751 froni a different surgeon, a particular set of surgeons that the surgeon has identified, or the entire set of available case data from all surgeons, This information may be stored in the surgeon database or stored in the patient database, For example, if the surgeon desires to know if the knee is 'too tight' or 'too loose' in certain regions or in general, the surgeon may choose to have this indication be relative to the set of force readings that a particular set of surgeons, or the surgeon himself, have indicated as being 'too tight' or 'too loose' in previous cases, The surgeon may also choose to have feedback on the particular techniques that have been used by the surgeon or a defined set of surgeons in the past to handle clinical situations that closely match the sensor data for the surgeon's current case, Exemplary feedback includes providing an indication, such as a text message or graphical symbol, identifying a technique. Exemplar}' techniques include using a thicker shim, or pie-crusting a certain ligament.

[0063] Computing system 100 further includes a user interface 128, User interface

128 provides an interface for an operator to provide information to force analysis software 114 and to receive information from force analysis software 114, User interface 128 includes input devices 130 and output devices 132. Exemplary input devices 130 include a touch display, a keyboard, a mouse, one or more buttons or switches, a CD drive, a floppy drive, an interface to a network (wireless or wired), and other suitable devices for providing

information to controller 106, Exemplary output devices 132 include a display (such as a touch screen), lights, printer, and other suitable devices for presenting information from controller 106,

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[0064] in one embodiment, user interface 128 includes a graphical user interface through which an operator may provide information to force analysis software 114 with input devices 130 and receive information from force analysis software 1 14 through output devices 132.

[0065] Referring to Fig. 4, in one embodiment, computing system 100 communicates with one or more other computing devices over a network 150, such as a server computer 156 associated with a hospital or surgical center. Network 1 0 may be any suitable connection between computing system 100 and server computer 156, such as a local area network, a wide area network, a wireless network, or other suitable networks. In one embodiment, network 150 utilizes the Internet for at least a portion of the connection between computing system 100 and server computer 156.

[0066] In one embodiment, force data database 1 16, shim database 1 18, provisional database 120, and surgeon database 122 are stored on a memory 158 accessible by server computer 156. By having force data database 116 located on memory 158, no patient specific data needs to be stored on computing system 100. In one embodiment, memory 158, includes a patient database 126 which stores the medical record information for a plurality of patients. The patient database may store information regarding the surgery being performed including force data related to provisional 20 and screenshots of the user interfa ce portions provided on display 132.

[0067] Referring to FIG. 5, an exemplar display screen 200 for user interface 128 is shown. Display screen 200 includes a provisional representation 202 of a top surface of

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BDDB01 9027443vl ZIM0875-20/ZI-00751 provisional 20. Also shown on display screen 200 are sensor icons 204A-L indicating the location of each sensor 42 included in provisional 20. In the illustrated embodiment,

provisional 20 includes twelve sensors 42. In the illustrated embodiment, a lateral

compartment 207 of provisional 20 includes sensors 42A-F which correspond to sensor icon 204A-F and a medial compartment 208 of provisional 20 includes sensors 42G-L which correspond to sensors 204G-L.

[0068] The sensors 42 experience various levels of force from femur 16 when

provisional 20 is inserted into knee joint 10. The force analysis software 1 14 based on the relative location of each of sensors 42 and the amount of force experienced by each sensor determines a location of a mean force applied from the femur on the tibia . The location of the mean force is represented in display screen 200 by a mea force center indicator 206, In one embodiment, mean force center indicator 206 is shown in a first color and sensors 204 are shown in a second color. In one example the first color is red and the second color is gold. In one embodiment, sensors icons 204 provide an indication of a level of force experienced by the respective sensor. Exemplary indications include color, color intensity, size, and other distinguishable features.

[0069] In the illustrated embodiment, display screen 200 also includes a bounded area

210. The bounded area 210 identifies an area in which the force delta would be considered small enough to result in a kinematically sound knee. The mean force center indicator 206 is shown partially overlapping bounded area 210. Therefore, the current force measurements result in a knee which is close to being considered kinematically sound. By adjusting

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BDDB01 9027443vl ZIM0875-20/ZI-00751 provisional 20 with a shim 30, the location of mean force center indicator 206 may be altered. Further, by a ltering the ligaments of the knee the location of the mean force center indicator may be adjusted, An exemplary alteration is pie-crusting the ligaments.

[0070] Bounded area 210 is shown slightly medialized and being generally polygonal in shape. In one embodiment, the shape and location of bounded area 210 is settable by the user and stored in database 122. As such, a surgeon may establish their own custom bounded area 210. In one embodiment, the shape and location of bounded area 210 is set by the implant manufacturer. In one example, the shape and location of bounded area 210 is retrieved from a surgeon database 122 or provisional database 120 based on the sensor provisional being used.

[0071] In one embodiment, computing system 100 includes an audio interface as an exemplary output device 132. With the audio interface, a speaker may provide audio

feedback to the surgeon so that the surgeon does not need to be looking at display screen 200 or display screen 220. Audio indications may be provided to indicate various device states to the surgeon while he is looking at the knee instead of the device display, and/or to provide additional confirmation of the visual indications. These audio indications may include confirmations of button presses, wireless connections being made or interrupted (alarm), the presence of the mean force center indicator 206 in bounded area 210 or region 268 (see FIG. 13 A) via a variable or stepped frequency tone, or a variable frequency click (an exemplary variable frequency click is similar to Geiger Counter), the force sensors being saturated (force overload), the battery of provisional 20 ranning out, the sound of a photo being taken when

■■ 23 -

BDDB01 9027443vl ZIM0875-20/ZI-00751 selecting camera button 246, beeping noises when mean force center indicator 206 is moving, and other such indications.

[0072] In one embodiment, an audio only interface is provided to the user, In this case, computing system 100 may include recorded vocalized statements and instructions, for example.

[0073] Referring to FIG. 6, a second display screen 220 is shown. Display screen 220 includes provisional representation 202 and sensor icons 222A-L indicating both the location of each sensor 42 included in provisional 20 and a measure of the force reading of each sensor 42 included in provisional 20. In one embodiment, a value is provided on each sensor icons 222. In one embodiment, the value corresponding to each sensor icons 222 is the actual force measured by the respective force sensor, In one embodiment, the value corresponding to each sensor icons 222 is a normalized value of the force measured by the respective force sensor 42. In one embodiment, the value corresponding to each of sensor icons 222 indicates a range that the actual force of the force sensor falls within. For example, a "0" indicates generally no force; a "1" indicates a force within a first range of values; a "2" indicates a force within a second range of v alues, the second range of values being higher than the first range of values, and so on.

[0074] In one embodiment, the operator may change the force value assigned to a given icon 222 to see the effect on the mean force center indicator 206. In this embodiment, screen 200 and screen 220 are displayed at the same time. After a period of time or other input, the value of the icon 222 returns to the corresponding force experienced by the sensor.

■■ 24 -

BDDB01 9027443vl ZIM0875-20/ZI-00751

[0075] As shown in FIG. 6, the value corresponding to each of sensor icons 222 is a

"0" value. Since all of the sensors 42 has a "0" value, mean force center indicator 206 is shown in the exact center of provisional representation 202. Referring to FIGS. 7 and 8, display screen 200 and display screen 220 illustrate the location of mean force center

indicator 206 when the force distribution of force sensors 204 is far medialized. Referring to FIGS. 9 and 10, display screen 200 and display screen 220 illustrate the location of mean force center indicator 206 when the force distribution of force sensors 204 is far lateralized. Referring to FIGS. 11 and 12, display screen 200 and display screen 220 illustrate the location of mean force center indicator 206 when the force distribution of force sensors 204 results in mean force center indicator 206 being located within the perimeter of bounded area 210.

[0076] In one embodiment, display screen 200 and display screen 220 are displayed at the same time on a display 132. In one embodiment, display screen 200 and display screen 220 are not displayed simultaneously on a display 132. In this embodiment, an input is provided to toggle between display screen 200 and display screen 220.

[0077] Referring to FIG. 13, display screen 200 illustrates an image of another exemplar}_' tibia provisional 228. Tibia provisional 228 includes twelve force sensors, represented by sensor icons 204A-L. The sensors are divided into two groups. A first group including sensors 204A-F and a second group including sensors 204G-L. In addition, tibia pro visional 228 includes a plurality of sensors, represented by sensor icons 230A-C, which are positioned along the lateral posterior ridge 232 of tibia provisional 228 and a plurality of sensors, represented by sensor icons 230D-F, which are positioned along the medial posterior

■■ 25 -

BDDB01 9027443vl ZIM0875-20/ZI-00751 ridge 234 of tibia provisional 228. Exemplary force sensors for positioning along the

posterior ridge include force sensing resistor or capacitive flex circuits, piezoelectric film, piezoelectric elements, piezoresistive and piezoelectric polymers, metal foil strain gages, semiconductor strain gages, piezoresistive and capacitive pressure sensors, interferometric optical sensors, path displacement optical sensors, optical fiber force sensors, and other suitable sensing technologies. Sensors 230A-F monitor force placed on the respective posterior ridge of tibia provisional 228 due to the femur 16 rolling upon or otherwise

impacting the posterior ridge of tibia provisional 228.

[0078] Tibia provisional 228 also includes a plurality of sensors, represented by sensor icons 236A-D, which are positioned proximate the post of tibia provisional 228. The post of tibia provisional 228 is positioned under a central, posterior portion of the

contoured top surface 24 of ti bia provisional 228. The post is received in a recess in resection surface 14 of tibia 12. In one embodiment, sensors 236 are strain gages located under the spine of tibia pro visional 228. The strain data is communicated to computing system 100 and is represented on display screen 200 to provide an indication to the operator of the amount of strain experienced by the post region of tibia provisional 228. The operator may use this information to determine if the amount of force being applied on the spine of tibia provisional 228 requires surgical action or an upgrade to another implant type.

[0079] As shown in FIG. 13, mean force center indicator 206 is still represented.

Further, a compartment force center indicator 262 is provided for each group of sensors. In the illustrated embodiment, force center 262A is provided for sensors 204A-F and force

- 26

BDDB01 9027443vl ZIM0875-20/ZI-00751 center 262B is provided for sensors 204G-L. In the illustrated embodiment, circular dots represent the force centers 262 A-B and mean force center indicator 206, In one embodiment, force center 262A-B are shown in a first color and mean force center indicator 206 is shown in a second color. In one embodiment, force center 262A-B and mean force center indicator 206 are illustrated in other ways to distinguish between force center 262A-B and mean force center indicator 206.

[0080] In one embodiment, the location of eac of force center 262A-B is determined by summing the vectors to each sensor from the centroid position of the sensors times the force above a bias or noise level experienced by the respective sensor. The summed value is divided by the sum of the forces from ail of the sensors 204 within the respective group. The respective force center location is an offset from the centroid location by the vector provided by the above calculation.

[0081] The mean force center indicator 206 may be determined in the same manner by considering all of the sensors 204A-L. In one embodiment, wherein there are two groups of sensors 204, mean force center indicator 206 is located at a midpoint of a line connecting the compartment force center indicator 262 of each of the two groups of sensors.

[0082] Referring to FIG. 13A, another exemplar display screen 200 is shown wherein bounded area 210 includes multiple levels. A first level, bounded by the perimeter of bounded area 210, represents the area corresponding to a structurally sound knee. A second level, bounded by a region 268, is a sub-region of bounded area 210 and

represents an area corresponding to an optimized knee.

■■ 27 -

BDDB01 9027443vl ZIM0875-20/ZI-00751

[0083] in one embodiment, a user may change the shape and/or size of one or both of bounded area 210 and region 268, Exemplary methods of adjusting the characteristics of bounded area 210 and region 268 include selection from a number of predefined shapes in a preferences menu or via a touch/drag technique through display screen 200. Exemplary touch/drag techniques include a multi-touch method for increasing the width or height of either indicator.

[0084] Referring to FIG. 14, display screen 220 displays sensor icons 254A-L for sensors 204A-L, sensor icons 280A-F for sensors 230A-F, and sensor icons 286A-D for sensors 236A-D. The sensor icons function in the same manner as sensor icons 222. In one embodiment, display screen 200 and display screen 220 are displayed simultaneously on a display device 132 associated with computing system 100.

[0085] Referring to FIG. 16, the sensor values for sensor 204D (represented by sensor

254D), sensor 204H (represented by sensor 2541 ! }. sensor 204J (represented by sensor 254J), sensor 204K (represented by sensor 254K), sensor 236A (represented by sensor icon 286A), and sensor 236A (represented by sensor icon 286A) have changed from FIG. 14, The result of this change is illustrated in FIG. 15, As shown in FIG. 15, the location of force center 262A (which now coincides generally with the location of sensor 204D) , force center 262B, and mean force center indicator 206 have changed.

[0086] In addition to mean force center indicator 206 and 262A-B, display screen 200 in FIG. 15 includes a representation 270 of the forces experienced by the post region of tibia

- 28

BDDB01 9027443vl ZIM0875-20/ZI-00751 provisional 228. Representation 270 provides both an indication of the magnitude of the force in the post region of tibia provisional 228 and the portions of the post region

experiencing the greater force, In the illustrated embodiment, representation 270 is circular and as the force magnitude increases the shape of representation 270 sweeps through a larger arc. At smaller force magnitudes, the shape of representation 270 is generally semi-circular while at larger forces the shape of representation 270 is generally about 300 degrees of a circle. In one embodiment, as the force magnitude increases a color and/or intensity of representation 270 changes. As an example, when the force exceeds a threshold a color of the representation changes to red indicating that there is excessive force on the post. The arc portion of representation 270 is centered on the perimeter portion of the post experiencing the most force, The magnitude and force direction of the post area, in one embodiment, is determined by the values of sensors 236A-D. in one example, the magnitude is a sum of the force recorded by sensors 236A-D and the direction is provided by having the midpoint of the arc portion located at the location of the one of sensors 236A-D ha ving the largest force reading or if two sensors 236 A-D have the same force reading then the midpoint of the arc portion is located halfway between the location of the two sensors 236 A-D. The magnitude and force direction of the post area, in one embodiment, is determined by the values of sensors 236 A-D and at least one of sensors 204 A-L and sensors 230A-F.

[0087] Referring to FIG. 17, an exemplary spread indicator 272 is shown. The sensor force values in FIG. 1 7 are the same as FIG. 16. Spread indicator is a visual representation, such as an oval or other geometric shape, displayed around mean force center indicator 206 to

- 29

BDDB01 9027443vl ZIM0875-20/ZI-00751 indicate the spread of the forces across the surface of tibia provisional 228, In one

embodiment, the spread indicator 272 is an oval shape and the ratio of the major and minor axis lengths provides an indication of the distance between force center 262 A. and force center 26213. A flatter oval correlates to a greater distance between force center 262A and force center 262B.

[0088] In one embodiment, spread indicator 272 provides an indication of the

relationship of condylar forces. In one example, an overall size of spread indicator 272 indicates a magnitude of the forces been applied to the tibia! surface of tibia provisional 228. The less force the smaller the oval, the greater the force the bigger the oval .

[0089] In one embodiment, spread indicator 272 is an oval and a linear regression is performed determine the best fit line to a collection of points; where the points are placed along the vector from the sensor centroid position to each sensor, weighted in distance by both the actual distance to the sensor from the centroid and the force reading of the sensor.

The resulting best fit line would define the major axis of the oval indicator 272. A measure of the line fit error across the points, such as the RMS error, would define the width of the oval indicator 272 relative to its length. For example, if all points fit well to the line, the ova! indicator 272 would be flat, whereas if there is no correspondence to a line for the point spread, the oval indicator 272 would be circular.

[0090] Referring to FIG. 18, an exemplary spread indicator 274 is shown. The sensor force values in FIG. 18 are the same as FIG. 16. Spread indicator 274 is a visual

BDDB01 9027443vl ZIM0875-20/ZI-00751 representation, such as an oval or other geometric shape, displayed around mean force center indicator 206 to indicate the spread of the forces across the surface of tibia provisional 228.

[0091] In the illustrated embodiment, the spread indicator 274 is a oval shape and the average position of compartment force center indicator 262 relati ve to its compartment center for both of the compartment force indicators 262A-B could be used to position the oval about the overall force indicator such that the oval center is offset from the overall force center in a way that indicates where the average compartment force is relative to the compartment force centers. For example, if both of the compartment force indicators are at the medial extremes of their compartments, the oval would appear about the overall force center dot such that the dot would be located at die medial side of the oval. A second spread indicator 276 provides an indication of the spread of the compartment force centers away from the average location of each within their respective compartment. The spread would be used to stretch the oval in the direction of the spread. For example, if the medial condyle indicator 262B was at an extreme medial position within its compartment and die lateral condyle indicator 262A was at a lateral position within its compartment, the oval would appear to be Tat', and if the medial indicator 262B was lateral, with the lateral indicator 262A was medial, the oval would be 'skinny'. If both force indicators 262A and 262B were located medially, the oval would be circular.

[0092] In another such instance of a spread indicator, circles would appear about each of the compartment force indicators 262A-B in addition to, or instead of, the mean force center indicator 206. in this case, the size of the circles about force indicators 262A-B would

31

BDDB01 9027443vl ZIM0875-20/ZI-00751 indicate the magnitude of the overall compartment force and/ or the overall force, possibly in addition to the positional shift of spread indicator 274 described above.

[0093] Referring to FIG. 19, the forces acting on the sensors 236A-D have been removed. Assuming the knee joint 10 is in full flexion at this point, the operator may note this configuration of knee joint 10 by selecting input button 240, vvhich in one embodiment, is a soft key on a touch screen. Computing system 100 stores the location values of force center 26 Λ and force center 262 B in force database 1 16. The operator may now move the knee joint 10 to a fully extended position to observe the forces in the new position. These forces are illustrated in FIG. 20

[0094] Referring to FIG. 20, force center 262A and force center 262 B have moved due to changes in force experienced by tibia provisional 228. The locations marked in the full flexion position of knee joint 10 remain shown on display screen 200 for reference by the operator as icons 310A-B. In one embodiment, the color of icons 310A-B corresponds to a color of select input button 242, Now that the knee joint 10 is in full extension, an operator may select input button 242 to indicate that the knee is in full extension. Computing system 100 will store these extension positions of force center 262A-B in force database 1 16. In a similar fashion, for both flexion and extension, computing system 100 stores the location values of mean force center indicator 206 in the force database 1 16,

[0095] In one embodiment, computing system 100 in addition to mean force center indicator 206, force center 262A-B, and the historical markers 310A-B and 312, also

32

BDDB01 9027443vl ZIM0875-20/ZI-00751 illustrates the path that each of mean force center indicator 206 and force centers 262A-B take from the respective historical markers positions 310A-B and 312 to their current

positions, These paths are illustrated as paths 314A-B and 316, respectively, In one

embodiment, a size of the path elements, i llustratively dots, spacing of path elements, or color intensity of path el ements may be varied to indicate the speed of change of the force during the motion. In one embodiment, each path may fade or be selectively erased in a variety of ways, including but not limited to time based techniques, having a maximum trail length, and resetting the trail when the flexion button 240, extension button 242, or clear button 244 is selected. The clear button erases all historical markers from display screen 200,

[0096] In one embodiment, computing system 100 retains multiple instances of the historical markers for both flexion and extension in database 116. Referring to FIG. 22, markers 330A-B correspond to the compartment force centers for a first reading of the knee joint 10 in one of flexion and extension and markers 332A-B correspond to the compartment force centers for a second reading of knee joint 10 in the other of flexion and extension,

Markers 330 A-B and 332A-B correspond to a first movement of the knee joint 10 between flexion and extension. Markers 334A-B correspond to the compartment force centers for another reading of the knee joint 10 in one of flexion and extension and markers 336 A-B correspond to the compartment force centers for another reading of knee joint 10 in the other of flexion and extension, Markers 334A-B and 336 A-B correspond to a second movement of the knee joint 10 between flexion and extension. In a similar manner, markers 338A-B correspond to the compartment force centers for another reading of the knee joint 10 in one of

BDDB01 9027443vl ZIM0875-20/ZI-00751 flexion and extension and markers 340A-B correspond to the compartment force centers for another reading of knee joint 10 in the other of flexion and extension, Markers 338A-B and 340A-B correspond to a third movement of the knee joint 10 between flexion and extension. By maintaining markers for multiple movements of knee joint 10, the operator is able to visualize whether a given change in tibia provisional 228, such as a different shim, or in knee joint 10 is an improvement or not, In one embodiment, the markers for each run are color coded to their respective movement of the knee joint 10. In one embodiment, the markers for each run have different intensities corresponding to their respecti ve movement of the knee joint 10. In one embodiment, older runs are more faded than later runs.

[0097] Referring to FIG. 23, historical paths are maintained by computing system 100 to provide a visual representation to the user of changes in the forces experienced by tibia provisional 228 over time. In the illustrated embodiment, historical paths 350A-B correspond to historical markers 330 A-B and 332A-B in FIG. 22. Historical paths 352A-B correspond to historical markers 334A-B and 336A-B in FIG. 22. Historical paths 354A-B correspond to historical markers 338A-B and 340A-B in FIG. 22.

[0098] In one embodiment, the operator may capture screenshots by selecting button

246. The screenshots may be replayed by selecting button 248. Each image will be stored chronologically in force data database 116, These images can be replay one at a time by pressing button 248, stored as pre-op or post-op in force data database 116, or scrolled like a slide show. The images can also be downloaded and associated with the patient in patient database 126.

34

BDDB01 9027443vl ZIM0875-20/ZI-00751

[0099] in one embodiment, inputs to the computing system 100 are stored and uploaded to server 156 for later retrieval. Exemplary inputs include recorded force data plus timestamps, any event based info including button presses, screen captures, qualitative surgeon observations, and other suitable information which would permit regeneration of the output of the computing system 100, In one embodiment, the qualitative surgeon feedback may be provided either during the procedure via button presses or vocal indications received through a microphone or after the procedure during a replay of the procedure. Exemplar}' qualitative surgeon feedback includes qualitative assessments of the fit, such as 'too tight', or 'too loose'. This information may be stored for later retrieval.

[00100] Turning to FIG. 24, in one embodiment, a display screen 223 is presented including both display screen 200 and display screen 220. In relation to display screen 223, the sensor icons in display screen 220 are inputs whereby an operator may select a given input to increase or decrease a force value. In one embodiment, a right mouse click increases the force and a left mouse click reduces the force. The result of changing the force is shown in the display screen 200 portion of display screen 223. Through display screen 223, computing system 100 is providing a simulation tool for the operator. By manipulating the various force values in display 220, the operator attempts to move mean force center indicator 206 into a given region 370 of bounded area 210. In the illustra ted embodiment, mean force center indicator 206 is represented by a golf ball and region 370 is shaped like a hole in a green. As the sensor values are manipulated in display screen 220, the location of mean force center indicator 206 is adjusted.

■■ 35 -

BDDB01 9027443vl ZIM0875-20/ZI-00751

[00101] in one embodiment, as mean force center indicator 206 approaches region 370, sound effects are used to provide feedback. A near miss results in a first sound effect while a successful alignment of mean force center indicator 206 in region 370 results in a second sound effect. By using the simulation tool, as operator becomes more aware of the effect of altering force values in various points of tibia provisional 228. Other exemplary icon changes include a smiley face and frowny face depending on proximity of mean force center indicator 206 to region 370 or thumbs up and thumbs down depending on proximity of mean force center indicator 206 to region 370.

[00102] in one embodiment, the simulation tool may provide additional visual

indicators. Exemplary visual indicators include a posterior ridge force level indicator, a medial force center indicator, a lateral force center indicator, a post force level mdicator, and a spread force indicator.

[00103] While this invention has been described as having an exemplary design, the present invention may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.

36

BDDB01 9027443vl

Claims

ZIM0875-20/ZI-00751 Claims:

1. A user interface generated with a computing device by instructions stored on at least one computer-readable medium, the user interface for presenting on a display objects related to a knee joint, at least one of the objects being based on data from a plurality of sensors which are located between the femur and the tibia, the user interface comprising:

a representation of an area of the knee joint for presentment on the display: and a force center indicator for presentment on the display, the user interface providmg an indication of when a position of the force center indicator corresponds to a desired position of the force center indicator, the position of the force center indicator being determined by an electronic controller of the computing device based on data from the plurality of sensors.

2. The user interface of claim 1, wherein a first characteristic of the force center indicator changes as a magnitude of the force sensed by the plurality of sensors changes.

3. The user interface of claim 1, further comprising a bounded region for presentment on the display, the indication of when the position of the force center indicator corresponds to the desired position corresponding to the force center indicator being located within the bounded region.

4. The user interface of claim 3, wherein the bounded region corresponds to a structurally sound knee.

5. The user interface of claim 4, further comprising a second bounded region for

presentment on the display, the second bounded region corresponds to an optimized knee.

BDDB01 9027443vl ZIM0875-20/ZI-00751

6. The user interface of claim 1, further comprising a bounded region for presentment on the display, the indication of when the position of the force center indicator corresponds to the desired position being an audio indication presented when the force center indicator is within the bounded region.

7. The user interface of claim 1, wherein the representation of the area of the knee joint for presentment on the display is a two-dimensional view.

8. The user interface of claim 1 , wherein the representation of the area of the knee joint for presentment on the display is a representation of a plane which includes medial-lateral information regarding the knee joint and anterior-posterior information regarding the knee joint.

9. The user interface of claim 8, wherein the representation of the area of the knee joint for presentment on the display is a representation of a provisional which is positioned between the femur and the tibia, the provisional including the plurality of sensors.

10. The user interface of claim 9, wherein the representation of the provisional is provided to the computing device from the provisional.

1 1 . The user interface of claim 9, wherein location information related to the plurality of sensors is provided to the electronic controller from the provisional .

12. A user interface generated with a computing device by instructions stored on at least one computer-readable medium, the user interface for presenting objects on a display related to a knee joint, at least one of the objects being based on data from a plurality of sensors which are

38

BDDB01 9027443vl ZIM0875-20/ZI-00751 located between the femur and the tibia and supported by a device having a posterior ridge, the user interface comprising:

a representation of an area of the knee joint for presentment on the display; and at least one indicator for presentment on the display, the at least one indicator

indicating a force level on the posterior ridge of the device, the force level on the posterior ridge being determined by an electronic controller of the computing device based on data from the plurality of sensors.

13. The user interface of claim 12, wherein the at least one indicator includes a first indicator which indicates a medial force level and a second indicator which indicates a lateral force level.

14. The user interface of claim 12, wherein a first characteristic of the at least one indicator changes as a magnitude of the force lev el sensed by the plurality of sensors changes.

15. The user interface of claim 12, wherein the representation is a two-dimensional view.

16. The user interface of claim 12, wherein the representation is a representation of a plane which includes medial -lateral information regarding the knee joint and anterior-posterior information regarding the knee joint.

17. The user interface of claim 16, wherein the representation is a representation of a

provisional which is positioned between the femur and the tibia, the provisional including the plurality of sensors.

18. The user interface of claim 12, further comprising a force center indicator for

presentment on the display, the user interface providing an indication of when a position of

39

BDDB01 9027443vl ZIM0875-20/ZI-00751 the force center indicator corresponds to a desired position of the force center indicator, the position of the force center indica tor being determined by an electronic controller based on data from the plurality of sensors,

19. A user interface generated with a computing device by instructions stored on at least one computer-readable medium, the user interface for presenting objects on a display related to a knee joint, at least one of the objects being based on data from a plurality of sensors which are located between the femur and the tibia, the user interface comprising:

a representation of an area of the knee joint for presentment on the display;

an overall force center indicator for presentment on the display relative to the

representation;

a medial force center indicator for presentment on the display relative to the

representation; and

a lateral force center indicator for presentment on the display relative to the

representation, a position of the overall force center indicator, a position of the medial force center indicator, and a position of the lateral force center indicator being determined by an electronic controller of the computing de vice based on data from the plurality of sensors.

20. The user interface of claim 19, wherein a first characteristic of at least one of the overall force center indicator, the medial force center indicator, and the lateral force center indicator changes as a magnitude of the force sensed by the plurality of sensors changes.

21. The user interface of claim 19, further comprising a bounded region for presentment on the display, the bounded region providing an indication of a desired position of at least one of

- 40

BDDB01 9027443vl ZIM0875-20/ZI-00751 the overall force center indicator, the medial force center indicator, and the lateral force center indicator,

22. The user interface of claim 19, wherein the representation is a two-dimensional view.

23. The user interface of claim 19, wherein the representation is a representation of a plane which includes medial-lateral information regarding the knee joint and anterior-posterior information regarding the knee joint.

24. The user interface of claim 23, wherein the representation is a representation of a

25. A user interface generated with a computing device by instructions stored on at least one computer-readable medium, the user interface for presenting objects on a display related to a knee joint, at least one of the objects being based on data from a plurality of sensors which are located between the femur and the tibia, the user interface comprising:

a representation of an area of the knee joint for presentment on the display: and at least one indicator for presentment on the display, the at least one indicator

indicating a force level on a post of the device which is received in a recess in one of the femur and the tibia, the force level on the post being determined by an electronic controller of the computing device based on data from the plurality of sensors.

26. The user interface of claim 25, wherein the at least one indicator indicates both a

magnitude of the force le vel and a portion of the post that is experiencing the greater force.

- 41

BDDB01 9027443vl ZIM0875-20/ZI-00751

27. The user interface of claim 26, wherein the at least one indicator includes a first indicator having a geometric shape, a colored region of the geometric shape indicating the magnitude of the force level and a position of the colored region indicating the portion of the post that is experiencing the greater force.

28. The user interface of claim 27, wherein the geometric shape is circular.

29. The user interface of claim 25, wherein a first characteristic of the at least one indicator changes as a magni tude of the force level sensed by the plurality of sensors changes.

30. The user interface of claim 25, wherein the representation is a two-dimensional view.

31. The user interface of claim 25, wherein the representation is a representation of a plane which includes mediaHateral information regarding the knee joint and anterior-posterior information regarding the knee joint.

32. The user interface of claim 31, wherein the representation is a representation of a

33. The user interface of claim 25, further comprising a force center indicator for

presentment on the display, the user interface providing an indication of when a position of the force center indicator corresponds to a desired position of the force center indicator, the position of the force center indica tor being determined by the electronic controller based on data from the plurality of sensors,

34. A user interface generated with a computing device by instructions stored on at least one computer-readable medium, the user interface for presenting objects on a display related to a

- 42

BDDB01 9027443vl ZIM0875-20/ZI-00751 knee joint, at least one of the objects being based on data from a plurality of sensors which are located between the femur and the tibia, the user interface comprising:

a representation of an area of the knee joint for presentment on the display;

a force center indicator for presentment on the display; and

a spread force indicator for presentment on the display, the spread force indicator providing an indication of a spread of the forces across the area of the knee joint, the position of the force center indicator and the spread force indicator being determined by an electronic controller of the computing device based on data from the plurality of sensors.

35. The user interface of claim 34, wherein the spread force indicator is a geometric shape, wherein a perimeter of the geometric shape provides the indication of the spread of forces across the area of the knee joint.

36. The user interface of claim 34, wherein the force center indicator is an overall force center indicator and the spread force indicator surrounds the overall force center indicator.

37. The user interface of claim 34, wherein the spread force indicator is an oval shape and a ratio of a major axis of the oval and a minor axis of the oval provides an indication of a distance between a medial force center and a lateral force center.

38. The user interface of claim 34, wherein the spread force indicator is an oval shape which provides an indication of a relationship of condylar forces.

39. The user interface of claim 34, wherein the spread force indicator is an oval shape and the force center indicator is an overall force center indicator, the user interface further comprising a medial force center indicator and a lateral force center indicator, a position of the oval

■■ 43 -

BDDB01 9027443vl ZIM0875-20/ZI-00751 relative to a position of the overall force center indicator provides an indication of the position of the medial force center indicator relative to a center of a medial region and the position of the lateral force center indicator relative to a center of the lateral region,

40. The user interface of claim 34, wherein the representation is a two dimensional view.

41. The user interface of claim 34, wherein the representation is a representation of a plane which includes medial-lateral information regarding the knee joint and anterior-posterior information regarding the knee joint.

42. The user interface of claim 41 , wherein the representation is a representation of a

43. A user interface generated with a computing device by instructions stored on at least one com uter-readable medium, the user interface for presenting objects on a display related to a knee joint, at least one of the objects being based on data from a plurality of sensors which are located between the femur and the tibia, the user interface comprising:

a representation of an area of the knee joint for presentment on the display; and a force center indicator for presentment on the display , the user interface providing an indication of a first position of the force center indicator when the knee joint is in a first position and of a second position of the force center indicator when the knee joint is in a second position, the first position of the force center indicator and the second position of the force center indicator being determined by an electronic control ler of the computing device based on data from the plurality of sensors.

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44. The user interface of claim 43, wherein the indication includes a first marker which marks the first position and a second marker which marks the second position.

45. The user interface of claim 44, further comprising a path indicator which indicates a movement of the force center indicator as the knee joint moves from the first position to the second position, the movement of the force center indicator being determined by the

electronic controller based on da ta from the plurality of sensors.

46. The user interface of claim 44, wherein the indication is a path indicator which indicates a mo vement of the force center indicator as the knee joint moves from the first position to the second position, the movement of the force center indicator being determined by the

electronic controller based on data from the plurality of sensors, a first end of the path indicator corresponding to the first position of the knee joint and a second end of the path indicator corresponding to the second position of the knee joint.

47. The user interface of claim 43, wherein the representation is a two-dimensonal view,

48. The user interface of claim 43, wherein the representation is a representation of a plane which includes medial -lateral information regarding the knee joint and anterior-posterior information regarding the knee joint.

49. The user interface of claim 48, wherein the representation is a representation of a

50. A user interface generated with a computing device by instructions stored on at least one computer-readable medium, the user interface for presenting objects on a display related to a

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a representation of an area of the knee joint for presentment on the display; an d a force center indicator for presentment on the display, the user interface providing an indication of a first position of the force center indicator when the knee joint is in a first position and of a second position of the force center indicator when the knee joint is in the first position, the first position of the force center indicator corresponding to a first

environment for the knee joint and the second position of the force center indicator

corresponding to a second environment of the knee joint, the first position of the force center indicator and the second position of the force center indicator being determined by an

electronic controller of the computing device based on data from the plurality of sensors,

51. The user interface of claim 50, wherein the second environment includes a change in at least one of the device and the knee joint relative to the first environment.

52. The user interface of claim 50, wherein the indication includes a first marker which marks the first position and a second marker which marks the second position.

53. A system for evaluating a knee joint, the system comprising:

a provisional selected from a plurality of provisionals, the provisi onal including a plurality of sensors which are located between the femur and the tibia when the provisional is positioned in the knee joint;

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BDDB01 9027443vl ZIM0875-20/ZI-00751 a computing system including a display, the computing system executes a processing sequence to identify the provisional and presents a user interface on the display to provide an indication of the force experienced by the plurality of sensors,

54. The system of claim 53, wherein the user interface is the user interface provided in at least one of claims 1-52.

55. The system of claim 53, further comprising a shim selected from a plurality of shims, wherein the computing system executes a processing sequence to identify the shim.

56. A user interface generated with a computing device by instructions stored on at least one computer-readable medium, the user interface for presenting objects on a display related to a simulation of a knee joint, the user interface comprising:

at least one input to specify force readings across an area of the knee joint; and a force center indicator for presentment on the display, the user interface providing an indication of a position of the force center indicator relative to a desired position of the force center indicator, the position of the force center indicator being determined by an electronic controller of the computing device based on the specified force readings across the area of the knee joint.

57. The user interface of claim 56, wherein a first characteristic of the force center indicator changes as a magnitude of the force sensed by the plurality of sensors changes.

58. The user interface of claim 56, further comprising a bounded region for presentment on the display, the indication of when the position of the force center indicator corresponds to the desired position corresponding to the force center indicator being within the bounded region.

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59. The user interface of claim 58, wherein the hounded region corresponds to a structural ly sound knee.

60. The user interface of claim 59, further comprising a second hounded region for presentment on the display, the second bounded region corresponds to an optimized knee.

61. The user interface of claim 56, further comprising a bounded region for presentment on the display, die indication of when the position of the force center indicator corresponds to the desired position being an audio indication presented when the force center indicator is within the bounded region.

62. The user interface of claim 56, wherein the representation is a two-dimensional view.

63. The user interface of claim 56, wherein die representation is a representation of a plane which includes medial-lateral information regarding the knee joint and anterior-posterior information regarding the knee joint.

64. The user interface of claim 63, wherein the representation is a representation of a

65. A user interface generated with a computing device by instructions stored on at least one computer-readable medium, the user interface for presenting objects on a display related to a simulation of a knee joint, the user interface comprising:

at least one input to specif simulation force readings across an area of the knee joint, each force reading corresponding to a respective sensor of a provisional; and

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BDDB01 9027443vl ZIM0875-20/ZI-00751 at least one visual indicator for presentment on the display, the at least one visual indicator providing a visual cue of the force experienced by the provisional based on the simulation force readings,

66. The user interface of claim 65, wherein the at least one visual indicator includes at least one of a force center indicator, a posterior ridge force level indicator, an overall force center, a medial force center indicator, a lateral force center indicator, a post force level indicator, and a spread force indicator.

67. A method of analyzing forces on a pro visional placed in a knee joint, the method

comprising the steps of:

receiving from the provisional information related to the provisional, the provisional including a plurality of sensors, the information related to the pro visional including at least one of identifying information for the pro visional, location information of the plurality of sensors of the provisional, and a visual representation of the provisional;

electronically receiving from the provisional information related to a force

experienced by the plurality of sensors of the provisional; and

determining at least one measure of the force experienced by the provisional from the information related to the force experienced by the plurality of sensors.

68. The method of claim 67, further comprising the step of receiving information related to a shim being used with the pro visional.

69. The method of claim 67, further comprising the step of displaying a visual indicator based on the at least one measure.

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70. The method of claim 69, wherein the visual indicator is one of a force center indicator, a posterior ridge force level indicator, an overall force center, a medial force center indicator, a lateral force center indicator, a post force level indicator, and a spread force indicator.

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